The Effect of Cervical Dilatation on Primary Dysmenorrhea

Not Applicable

• Conditions: Dysmenorrhea Primary
• Interventions: Procedure: Cervical dilatation

• Registration Number: NCT04682262
• Lead Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Brief Summary

Primary dysmenorrhea (PD) is defined as recurrent, crampy pain occurring with menses in the absence of identifiable pelvic pathology. Standard initial management of PD includes NSAIDs as a first-line treatment and oral contraceptives for the relief of pain and improved daily activity. In patients who have persistent dysmenorrhea despite medical therapy of NSAIDs and/or oral contraceptives, further investigation including pelvic ultrasound, hysteroscopy or laparoscopy may be needed to rule out other underlying pathologies. Historically, It is an old clinical observation that primary dysmenorrhea is often completely or partially relieved by childbearing. Similarly, the investigators have observed that the diagnostic/operative hysteroscopy led to relive of pain in most of the cases in our practice. Therefore, the investigators hypothesized that the process of cervical dilatation can have a role in reducing pain of patients with dysmenorrhea. In this randomized, controlled study, it was aimed to assess the effect of operational cervical dilatation on the pain in patients with primary dysmenorrhea.

Detailed Description

Patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation) will be assessed for the presence of primary dysmenorrhea by history taking and anamnesis. Patients will be randomized to have cervical dilatation and hysteroscopy or no intervention until the follow-up duration.

Study Timeline

• Study First Submitted: 2020-12-09
• Study Start: 2020-12-14
• Study First Submitted QC: 2020-12-20
• Study First Posted: 2020-12-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Primary Completion: 2021-04-14
• Study Completion: 2021-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Patients who applies to the outpatient clinic for reasons non-related to the dysmenorrhea (e.g. infertility investigation)
• Patients whose history and anamnesis indicate primary dysmenorrhea.
• Aged over 18 years old
• Nulliparous women

Exclusion Criteria

• History of uterine surgery/operation
• History and clinical examinations which are indicative of secondary dysmenorrhea (Endometriosis, Adenomyosis, Uterine myomas, Endometrial polyps, Cervical stenosis, etc.)
• Positive pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical dilatation	Cervical dilatation	Patients receive cervical dilatation up to 10 millimeter Hegar dilator under general anaesthesia. Patient undergo standard hysteroscopy operation.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Score	Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month	Patients are asked to mark their pain on a 10 point visual scale which variate between 0 (no pain) to 10 (unbearable pain).
Verbal multidimensional scoring system for assessment of dysmenorrhea severity	Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month	This scale assess the dysmenorrhea by grading the severity. The assessment includes working ability, systemic symptoms and the use of analgesics. The grades vary between grade 0, grade 1 (mild), grade 2 (moderate) and grade 3 (severe).
EQ-5D	Change between these periods: preoperative, postoperative 1st month, postoperative 2nd month	The EuroQol-5D (EQ-5D) is an instrument for measuring quality of life and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Trial Locations

Locations (1)

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital; 🇹🇷 Istanbul, Turkey